European Commission approves nasal spray vaccine FLUENZ for the prevention of seasonal influenza in children

PUBLISHED1 February 2011

Tuesday, 1 February 2011

AstraZeneca
announced today that the European Commission (EC) has granted marketing
authorisation to FLUENZ Influenza Vaccine (Live Attenuated, Nasal), a
nasally administered live attenuated influenza vaccine (LAIV), for
prevention of seasonal influenza for children 24 months to less than 18
years of age. This decision follows the positive opinion from the
Committee for Medicinal Products for Human Use (CHMP) on 22nd October
2010 and is applicable to the 27 Member States and the 3 European
Economic Area countries of the European Union.

“We are delighted that FLUENZ has received regulatory approval in
Europe since influenza creates a significant medical and economic burden
there and throughout the world. We hope that the availability of this
nasal spray influenza vaccine with its novel mechanism of action will
help reduce the spread of influenza,” said Alex Zukiwski, M.D.,
executive vice president and chief medical officer of MedImmune, the
biologics unit of AstraZeneca.

It is expected that the FLUENZ vaccine will be initially available in select European markets for the 2012-13 influenza season.

The EC decision and CHMP positive opinion were reached after a review
of data from 73 global clinical studies and US post-marketing studies
of more than 141,000 subjects conducted in 38 countries. Study
objectives included clinical safety and tolerability, clinical efficacy
and effectiveness, and immunogenicity.

NOTES TO EDITORS

About LAIV

Each dose of FLUENZ is formulated to contain three live attenuated
influenza virus strains, which are weakened so as to not cause illness.
The vaccine strains are selected annually by the World Health
Organization (WHO) based on anticipated circulating influenza strains
for the upcoming season.

The vaccine is administered by spraying into the nose where it
induces protective immunity. In several clinical studies it has
demonstrated superior efficacy in children 24 months to less than 18
years of age compared to traditional inactivated influenza vaccines that
are injected. The most common adverse events for LAIV include runny
nose or nasal congestion. The live influenza virus strains used in LAIV
are cold-adapted, temperature sensitive and attenuated.

In the US, FLUENZ is marketed by MedImmune under the trade name
FluMist (Influenza Vaccine Live, Intranasal). FluMist was approved by
the US Food and Drug Administration in 2003. The seasonal vaccine is
currently approved in five countries including the US and Canada.

About Influenza

Influenza is the most common vaccine-preventable disease in the
developed world. According to WHO estimates, seasonal influenza results
in three to five million cases of severe illness and up to half a
million deaths globally each year, primarily among the elderly. Rates of
infection are highest among children, with school-aged children
significantly contributing to spread of disease to their families,
communities and high-risk individuals.

Studies in several European countries have demonstrated that
hospitalisation rates associated with influenza are highest in young
children including those without underlying medical problems (Weigl et
al, 2002; Pitman et al, 2007; Gasparini et al, 2007; Lenglet et al,
2007; Jansen et al, 2007). Based on these accumulated data, many experts
include young children among those at high risk for severe influenza
disease and influenza-related complications (Heikkinen et al, 2006).

Influenza also has socio-economic consequences related to both direct
and indirect health care costs, including hospitalisations, work
absence and loss of work productivity when either a caregiver or child
is sick with influenza.

To date, seven EU countries (Finland, Austria, Estonia, Latvia, the
state of Saxony in Germany, Slovakia and Slovenia) recommend routinely
vaccinating young children against influenza with varying age limits. EU
and Member State policymakers continue to evaluate data on the impact
of influenza in children to best inform the potential expansion of
recommendations.

About MedImmune

MedImmune, the worldwide biologics unit for AstraZeneca PLC, has
approximately 3,500 employees worldwide and is headquartered in
Gaithersburg, Maryland. For more information, visit MedImmune’s website
at www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
with a primary focus on the discovery, development and
commercialisation of prescription medicines. As a leader in
gastrointestinal, cardiovascular, neuroscience, respiratory and
inflammation, oncology and infectious disease medicines, AstraZeneca
generated global revenues of US $33.3 billion in 2010. For more
information please visit: www.astrazeneca.com.

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